PsoriasisPhase 1/2NCT07623486
Trial of HSK44459 Cream for the Management Plaque Psoriasis
A Phase 1/2 study testing HSK44459 Cream in people with Psoriasis, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
Phase I Study Objectives: Primary: Assess the safety and tolerability of HSK44459 cream in 10 healthy adult participants and 10 patients with plaque psoriasis. Secondary: Evaluate the pharmacokinetic (PK) profile of HSK44459 cream in the same populations (healthy adults and plaque psoriasis patients). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- HSK44459 Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2026to Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Participants in Phase I Study:
- Able to communicate effectively with researchers, fully understand the study's purpose and requirements, voluntarily participate in the clinical trial, and sign a written informed consent form;
- Age at screening: 18-45 years (inclusive of boundary values), both male and female are eligible;
- Weight at screening: ≥50 kg (males), ≥45 kg (females); body mass index (BMI) between 19.0-27.0 kg/m² (inclusive of boundary values);
- At screening and before drug administration, the skin in the target application area has no ulcers, injuries, sunburn, erythema, papules, pigmentation, uneven skin tone, excessive freckles, or abnormal heat. Participants must agree to shave hair from this skin area (if present) to ensure uniform drug application and to distinguish skin conditions (e.g., edema, erythema, papules, increased temperature).
- The participant (and their partner, if applicable) agrees to have no plans for pregnancy, sperm donation, or egg donation during the study and for 3 months after drug administration. Effective non - pharmacological contraceptive measures (e.g., complete abstinence, condoms, intrauterine devices, partner sterilization) must be used.
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- Patients with Psoriasis in Phase I and Phase II Studies:
- Demographics:
- Fully understand the study, voluntarily participate, and sign the informed consent form;
- Age ≥18 years, gender - unrestricted;
- Able to understand and complete study - related scales, agree to have photographs taken of the lesion area, and comply with follow - up schedules and other protocol requirements.
- At screening: ≥50 kg (males), ≥45 kg (females); BMI between 19-27 kg/m² (inclusive of boundary values). Only applicable to Phase I study
- Disease - Related:
- Diagnosed with plaque psoriasis for ≥6 months (as of randomization);
- Plaque psoriasis has been stable in the past 4 weeks, defined as: no morphological changes or severe disease progression (as judged by the investigator).
- Both screening visits and baseline assessments meet the criteria for plaque psoriasis, and the following requirements must be satisfied simultaneously:
- Body surface area (BSA) of psoriatic lesions: 2%-20% (inclusive of both endpoints, excluding scalp, palms, and soles); Psoriasis Area and Severity Index (PASI): ≥2 (excluding scalp, palms, and soles); Investigator Global Assessment (IGA): ≥2 points.
- -The investigator assesses that the participant is suitable for topical treatment.
- Contraception Requirements:
- During the entire study period (from signing the informed consent form) and for 3 months after the last dose, women of childbearing potential and male participants who have not undergone vasectomy must use effective contraceptive measures. Effective contraceptive measures include: vasectomy, abstinence, intrauterine device (IUD), hormones (oral, patch, ring, injection, implant), and barrier methods (diaphragm, cervical cap, sponge, condom).
Who cannot join
- Healthy Participants in Phase I Study:
- Those with clinically significant abnormal results in vital signs, physical examination, laboratory tests (routine blood test, biochemical blood test, coagulation function, routine urine test), chest PA X - ray, abdominal color Doppler ultrasound, etc., and deemed unsuitable to participate in this trial by the investigator;
- Those with a history of heart - related diseases such as familial hereditary heart disease, ischemic heart disease, heart failure, malignant arrhythmia, etc.; those with a confirmed history of QTc prolongation; those with the following electrocardiogram (ECG) findings during the screening period:
- QT interval corrected by Fridericia's method (QTcF): > 450 ms for male subjects, > 470 ms for female subjects;
- Second - degree or third - degree atrioventricular block;
- Bundle branch block;
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- PR interval ≥ 220 ms; or those with ECG results that are judged by the investigator to be clinically significantly abnormal during the screening period;
- Those with a history of major diseases in the cardiovascular, respiratory, digestive, urinary, hematological, endocrine, immune, or nervous systems, or those who underwent major surgery within 3 months before the screening period or whose surgical incisions have not fully healed;
- Those known to be allergic to any component of the investigational drug or formulation, or those with allergic constitutions (e.g., allergic to two or more drugs, foods, or pollens); or those with a history of specific allergies (e.g., asthma, urticaria, eczema, etc.);
- Those with special dietary requirements and unable to comply with a unified diet;
- Those who consumed excessive tea, coffee, or caffeinated beverages (on average more than 4 cups per day, 1 cup = 250 mL) within 3 months before the screening; or those who took tea or any food or beverage containing caffeine (e.g., coffee, chocolate, etc.) within 48 hours before the first dosing; or those who do not agree to stop taking tea, coffee, or caffeinated foods or beverages during the trial;
- Those who ingested a large amount of beverages or foods rich in grapefruit (i.e., pomelo) (e.g., grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days before the screening; or those who ingested any beverage or food rich in grapefruit (i.e., pomelo) within 48 hours before the first dosing; or those who do not agree to stop drinking any beverage or food rich in grapefruit (i.e., pomelo) during the trial;
- Those with a history of alcohol abuse within 3 months before the screening, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of liquor with 40% alcohol content or 150 mL of wine), or those who cannot abstain from alcohol during the trial, or those with a positive alcohol breath test;
- Those who smoked more than 5 cigarettes per day (or used an equivalent amount of nicotine - containing products) within 3 months before the screening, or those who cannot refrain from smoking during the trial;
- Those who donated blood or had blood loss ≥ 400 mL (excluding menstrual blood loss in women) within 3 months before the screening, or plan to donate blood during the study period, or received blood transfusion or used blood products within 3 months before the screening;
- Those who took any prescription drugs, over - the - counter drugs, Chinese herbal medicines, or health supplements within 14 days before the screening or within 5 half - lives of the drug (whichever is longer);
- Those who participated in other clinical trials of drugs within 3 months before the screening; or those who plan to participate in other clinical trials during the trial;
- Those who were vaccinated with a live vaccine (except influenza vaccine) within 1 month before the screening, or those who plan to be vaccinated with a live vaccine during the trial;
- Those with a history of drug abuse, drug misuse, or drug dependence, or those with a positive drug abuse screening;
- Those who have one or more positive test results for hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and Treponema pallidum antibody during the screening period;
- Those with a history of fear of needles or blood, difficulty in blood collection, or inability to tolerate venipuncture for blood collection;
- Pregnant or lactating women; or those with a positive pregnancy test;
- Those whom the investigator deems to have poor compliance, or those with other factors that make them unsuitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled Phase I/II Clinical Study of HSK44459 Cream in Healthy Subjects and Patients With Plaque Psoriasis
Phase I
Study Objectives:
Read more
- Primary: Assess the safety and tolerability of HSK44459 cream in 10 healthy adult participants and 10 patients with plaque psoriasis.
- Secondary: Evaluate the pharmacokinetic (PK) profile of HSK44459 cream in the same populations (healthy adults and plaque psoriasis patients).
Participant Allocation:
- 10 healthy adults and 10 plaque psoriasis patients are enrolled. Participants are randomized to either the HSK44459 cream group (8 per population) or the vehicle (placebo - like) control group (2 per population).
Treatment Schedule:
- Day 1: Single - dose administration (one application).
- Days 2-3: Washout period (no medication).
- Days 4-9: Twice - daily administration.
- Day 10: One application.
Phase II
Study Objectives:
- Primary: Conduct a preliminary evaluation of the efficacy of HSK44459 cream in treating plaque psoriasis.
- Secondary: Assess the safety and tolerability of HSK44459 cream in plaque psoriasis patients.
Evaluate the PK profile of HSK44459 cream in plaque psoriasis patients.
Participant Allocation:
- 160 plaque psoriasis patients are enrolled and randomized in a 1:1:1:1 ratio to four groups: 1% HSK44459 cream (40 patients), 0.3% HSK44459 cream (40 patients), 0.1% HSK44459 cream (40 patients), or vehicle control (40 patients).
Treatment Schedule:
Phase II: The study consists of three phases (screening, treatment, and follow - up)
- Screening Period (D - 28 to D - 1): Eligible plaque psoriasis patients sign an informed consent form and complete screening assessments to establish baseline data.
- Treatment Period (W1D1 to W9D1 ± 3 days): After baseline evaluation, eligible patients are randomized. The first dose of the study drug is administered on W1D1, with twice - daily dosing for 8 weeks. Patients return to the study center at W3D1 ± 3, W5D1 ± 3, W7D1 ± 3, W9D1 ± 3, and W11D1 ± 3 for scheduled assessments and procedures.
- Follow - up Period (W9D1 ± 3 days to W11D1 ± 3 days, within 14 days after the last dose): Adverse events and concomitant medications are collected. A final safety visit (W11D1 ± 3 days) includes additional assessments and procedures.
In summary, this trial aims to comprehensively evaluate HSK44459 cream's potential as a treatment for plaque psoriasis, while also characterizing its safety, tolerability, and PK properties in both healthy individuals and patient populations.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK44459 CreamDrug
HSK44459 Cream
VehicleDrug
HSK44459 Vehicle
| Study group | Role | What they receive |
|---|---|---|
| HSK44459 Cream | Experimental | HSK44459 Cream Receives: Drug: HSK44459 Cream |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Psoriasis Area Severity Index 75 (PASI-75)
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The number of participants achieving PASI-75 (defined as a 75% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Measured: Baseline (Day 1) and Week 8
Secondary outcomes (4)
Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented (observed data only) for each arm. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Measured: Baseline (Day 1) and Week 8
Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)
Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) [higher scores indicate greater symptom severity]. The number of participants achieving PASI-90 (defined as a 90% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Measured: Baseline (Day 1) and Week 8
Number of Participants Achieving Psoriasis Area Severity Index 50 (PASI-50)
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The number of participants achieving PASI-50 (defined as a 50% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Measured: Baseline (Day 1) and Week 8
Change From Baseline in Body Surface Area (BSA) Involved by Psoriasis
The percentage of body surface area (BSA) covered by psoriatic lesions will be calculated. The BSA score represents the percentage of the patient's total body surface area affected by psoriasis. A negative change signifies clinical improvement.
Measured: Baseline (Day 1) and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start22 May 2026
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623486
- Sponsor's protocol ID
- HSK44459-T1-201
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled Phase I/II Clinical Study of HSK44459 Cream in Healthy Subjects and Patients With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07623486
- Acronym / sponsor ID
- HSK44459-T1-201
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 May 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I
Study Objectives:
- Primary: Assess the safety and tolerability of HSK44459 cream in 10 healthy adult participants and 10 patients with plaque psoriasis.
- Secondary: Evaluate the pharmacokinetic (PK) profile of HSK44459 cream in the same populations (healthy adults and plaque psoriasis patients).
Participant Allocation:
- 10 healthy adults and 10 plaque psoriasis patients are enrolled. Participants are randomized to either the HSK44459 cream group (8 per population) or the vehicle (placebo - like) control group (2 per population).
Treatment Schedule:
- Day 1: Single - dose administration (one application).
- Days 2-3: Washout period (no medication).
- Days 4-9: Twice - daily administration.
- Day 10: One application.
Phase II
Study Objectives:
- Primary: Conduct a preliminary evaluation of the efficacy of HSK44459 cream in treating plaque psoriasis.
- Secondary: Assess the safety and tolerability of HSK44459 cream in plaque psoriasis patients.
Evaluate the PK profile of HSK44459 cream in plaque psoriasis patients.
Participant Allocation:
- 160 plaque psoriasis patients are enrolled and randomized in a 1:1:1:1 ratio to four groups: 1% HSK44459 cream (40 patients), 0.3% HSK44459 cream (40 patients), 0.1% HSK44459 cream (40 patients), or vehicle control (40 patients).
Treatment Schedule:
Phase II: The study consists of three phases (screening, treatment, and follow - up)
- Screening Period (D - 28 to D - 1): Eligible plaque psoriasis patients sign an informed consent form and complete screening assessments to establish baseline data.
- Treatment Period (W1D1 to W9D1 ± 3 days): After baseline evaluation, eligible patients are randomized. The first dose of the study drug is administered on W1D1, with twice - daily dosing for 8 weeks. Patients return to the study center at W3D1 ± 3, W5D1 ± 3, W7D1 ± 3, W9D1 ± 3, and W11D1 ± 3 for scheduled assessments and procedures.
- Follow - up Period (W9D1 ± 3 days to W11D1 ± 3 days, within 14 days after the last dose): Adverse events and concomitant medications are collected. A final safety visit (W11D1 ± 3 days) includes additional assessments and procedures.
In summary, this trial aims to comprehensively evaluate HSK44459 cream's potential as a treatment for plaque psoriasis, while also characterizing its safety, tolerability, and PK properties in both healthy individuals and patient populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK44459 Cream | Experimental | Drug: HSK44459 CreamHSK44459 Cream |
| Vehicle | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Able to communicate effectively with researchers, fully understand the study's purpose and requirements, voluntarily participate in the clinical trial, and sign a written informed consent form;
- Age at screening: 18-45 years (inclusive of boundary values), both male and female are eligible;
- Weight at screening: ≥50 kg (males), ≥45 kg (females); body mass index (BMI) between 19.0-27.0 kg/m² (inclusive of boundary values);
- At screening and before drug administration, the skin in the target application area has no ulcers, injuries, sunburn, erythema, papules, pigmentation, uneven skin tone, excessive freckles, or abnormal heat. Participants must agree to shave hair from this skin area (if present) to ensure uniform drug application and to distinguish skin conditions (e.g., edema, erythema, papules, increased temperature).
- The participant (and their partner, if applicable) agrees to have no plans for pregnancy, sperm donation, or egg donation during the study and for 3 months after drug administration. Effective non - pharmacological contraceptive measures (e.g., complete abstinence, condoms, intrauterine devices, partner sterilization) must be used.
Key exclusion criteria (23 listed)
- Those with clinically significant abnormal results in vital signs, physical examination, laboratory tests (routine blood test, biochemical blood test, coagulation function, routine urine test), chest PA X - ray, abdominal color Doppler ultrasound, etc., and deemed unsuitable to participate in this trial by the investigator;
- Those with a history of heart - related diseases such as familial hereditary heart disease, ischemic heart disease, heart failure, malignant arrhythmia, etc.; those with a confirmed history of QTc prolongation; those with the following electrocardiogram (ECG) findings during the screening period:
- Those with a history of major diseases in the cardiovascular, respiratory, digestive, urinary, hematological, endocrine, immune, or nervous systems, or those who underwent major surgery within 3 months before the screening period or whose surgical incisions have not fully healed;
- Those known to be allergic to any component of the investigational drug or formulation, or those with allergic constitutions (e.g., allergic to two or more drugs, foods, or pollens); or those with a history of specific allergies (e.g., asthma, urticaria, eczema, etc.);
- Those with special dietary requirements and unable to comply with a unified diet;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK44459 CreamHSK44459 Cream | Drug | HSK44459 Cream |
| VehicleHSK44459 Vehicle | Drug | Vehicle |
Primary outcome
Number of Participants Achieving Psoriasis Area Severity Index 75 (PASI-75)
Time frame: Baseline (Day 1) and Week 8
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The number of participants achieving PASI-75 (defined as a 75% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
4 secondary outcomes
Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8
Time frame: Baseline (Day 1) and Week 8
Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)
Time frame: Baseline (Day 1) and Week 8
Number of Participants Achieving Psoriasis Area Severity Index 50 (PASI-50)
Time frame: Baseline (Day 1) and Week 8
Change From Baseline in Body Surface Area (BSA) Involved by Psoriasis
Time frame: Baseline (Day 1) and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HSK44459 Cream in people with Psoriasis, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving Psoriasis Area Severity Index 75 (PASI-75) (time frame: Baseline (Day 1) and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.